Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Philips Allura Xper and Azurion systems [Multiple model numbers] [HKMD No.: 100205, 100206, 110046, 11047, 200480].
According to the TGA, The manufacturer has become aware of several situations that can result in a loss of availability of the wireless foot switch during a procedure. Identified issues that may result in the wireless foot switch not being available are:
To date, the manufacturer has not received any reports of harm associated with any of the specific issues identified.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00599-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 Jul 2023